Northgate Technologies, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0073-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

Product Classification:

Class II

Date Initiated: May 24, 2017

Date Posted: November 15, 2017

Recall Number: Z-0073-2018

Event ID: 77367

Reason for Recall:

The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.

Status: Terminated

Product Quantity: 186

Code Information:

Model No. 9-195-371DS, Lot/Serial Number LDS12516

Distribution Pattern:

US Distribution to the following states : MA, NE and TN and Internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated